[Federal Register Volume 78, Number 184 (Monday, September 23, 2013)]
[Notices]
[Pages 58318-58320]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-23060]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-day Comment Request: The Framingham
Heart Study (FHS)
SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National Institutes of Health (NIH) has
submitted to the Office of Management and Budget (OMB) a request for
review and approval of the information collection listed below. This
proposed information collection was previously published in the Federal
Register on May 7, 2013, pages 26639-41 and allowed 60-days for public
comment. No public comments were received. The National Heart, Lung,
and Blood Institute (NHLBI), National Institutes of Health, may not
conduct or sponsor, and the respondent is not required to respond to,
an information collection that has been extended, revised, or
implemented on or after October 1, 1995, unless it displays a currently
valid OMB control number.
Direct Comments to OMB: Written comments and/or suggestions
regarding the item(s) contained in this notice, especially regarding
the estimated public burden and associated response time, should be
directed to the: Office of Management and Budget, Office of Regulatory
Affairs, [email protected] or by fax to 202-395-6974,
Attention: NIH Desk Officer.
[[Page 58319]]
Comment Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 30-days
of the date of this publication.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of data collection plans and
instruments, contact Dr. Gina Wei, Division of Cardiovascular Sciences,
NHLBI, NIH, Two Rockledge Center, 6701 Rockledge Drive, MSC 7936,
Bethesda, MD, 20892-7936, or call non-toll-free number (301) 435-0416,
or email your request, including your address to: [email protected].
Formal requests for additional plans and instruments must be requested
in writing.
Proposed Collection: The Framingham Heart Study, 0925-0216,
Revision National Heart, Lung, and Blood Institute (NHLBI), National
Institutes of Health (NIH).
Need and Use of Information Collection: The Framingham Heart Study
will continue to conduct morbidity and mortality follow-up, as well as
examinations, for the purpose of studying the determinants of
cardiovascular disease. Morbidity and mortality follow-up will continue
to occur in all of the cohorts (Original, Offspring, Third Generation,
Omni Group 1, and Omni Group 2). Examinations will continue to be
conducted on the Original, Offspring, and Omni Group 1 Cohorts. The
numbers of Offspring and Omni Group 1 participants to be examined for
this OMB submission are much smaller than those during the last OMB
approval period. This is because a great majority of these two cohorts
have already completed their examinations. The small number of
participants remaining to be examined is reflected in the decrease in
the estimated annualized burden hours for these two cohorts as well as
for the entire study, compared to the last OMB approval period.
OMB approval is requested for 3 years. There is no cost to the
respondents other than their time. The total estimated annualized
burden hours are 4264.
Estimated Annualized Burden Hours, Original Cohort
----------------------------------------------------------------------------------------------------------------
Number of Average time
Type of respondent Number of responses per per response Total annual
respondents respondent (in hours) burden hour
----------------------------------------------------------------------------------------------------------------
I. PARTICIPANT COMPONENTS
A. PRE-EXAM:............................
a. Telephone contact to set up 60 1 10/60 10
appointment........................
b. Exam Appointment, Scheduling, 55 1 35/60 32
Reminder, and Instructions.........
B. EXAM--Cycle 32:......................
a. Clinic exam...................... 25 1 45/60 19
b. Home or nursing home visit....... 25 1 65/60 27
C. ANNUAL FOLLOW-UP:....................
a. Records Request.................. 60 1 15/60 15
b. Health Status Update............. 45 1 15/60 11
----------------------------------------------------------------------------------------------------------------
SUB-TOTAL: PARTICIPANT *60 ............... ............... 114
COMPONENTS.....................
----------------------------------------------------------------------------------------------------------------
II. NON-PARTICIPANT COMPONENTS
A. Informant Contact (Pre-exam and 25 1 10/60 4
Annual Follow-up)......................
B. Records Request (Annual follow-up)... 50 1 15/60 13
----------------------------------------------------------------------------------------------------------------
SUB-TOTAL: NON-PARTICIPANT 75 ............... ............... 17
COMPONENTS.....................
----------------------------------------------------------------------------------------------------------------
* Number of participants as reflected in Rows I.A.a and I.C.a. above
Estimated Annualized Burden Hours, Offspring Cohort and Omni Group 1 Cohort
----------------------------------------------------------------------------------------------------------------
Number of Average time
Type of respondent Number of responses per per response Total annual
respondents respondent (in hours) burden hour
----------------------------------------------------------------------------------------------------------------
I. PARTICIPANT COMPONENTS
A. PRE-EXAM:
a. Telephone contact to set up apt or 300 1 10/60 50
Health status update...................
b. Appt. or update Confirmation......... 250 1 10/60 42
c. Food Frequency Form.................. 250 1 10/60 42
B. EXAM:
a. Clinic Exam.......................... 100 1 175/60 292
b. Home or nursing home visit........... 100 1 60/60 100
c. Consent Forms........................ 200 1 20/60 67
C. ANNUAL FOLLOW-UP:
a. Records Request...................... 2292 1 15/60 573
b. Health Status Update................. 1833 1 15/60 458
---------------------------------------------------------------
SUB-TOTAL: PARTICIPANT COMPONENTS... *2292 .............. .............. 1624
----------------------------------------------------------------------------------------------------------------
II. NON-PARTICIPANT COMPONENTS
A. Informant contact (Pre-exam and Annual 229 1 10/60 38
Follow-up).................................
B. Records Request (Annual follow-up)....... 2292 1 15/60 573
---------------------------------------------------------------
SUB-TOTAL: NON-PARTICIPANT 2521 .............. .............. 611
COMPONENTS.........................
----------------------------------------------------------------------------------------------------------------
* Number of participants as reflected in Rows I.C.a. above.
[[Page 58320]]
Estimated Annualized Burden Hours, Generation 3 Cohort and Omni Group 2 Cohort
----------------------------------------------------------------------------------------------------------------
Number of Average time
Type of respondent Number of responses per per response Total annual
respondents respondent (in hours) burden hour
----------------------------------------------------------------------------------------------------------------
I. PARTICIPANT COMPONENTS--ANNUAL FOLLOW-UP
A. Records Request.......................... 3212 1 15/60 803
B. Health Status Update..................... 3212 1 15/60 803
---------------------------------------------------------------
SUB-TOTAL: PARTICIPANT COMPONENTS....... * 3212 .............. .............. 1606
II. NON-PARTICIPANT COMPONENTS--ANNUAL FOLLOW-UP
A. Informant contacts....................... 160 1 10/60 27
B. Records Request.......................... 1060 1 15/60 265
---------------------------------------------------------------
SUB-TOTAL: NON-PARTICIPANT COMPONENTS... 1220 .............. .............. 292
----------------------------------------------------------------------------------------------------------------
* Number of participants as reflected in Rows I.A. and I.B. above.
Summary of 3 Tables Combined--Total Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average time
Type of respondent Number of responses per per response Total annual
respondents respondent (in hours) burden hour
----------------------------------------------------------------------------------------------------------------
Participants.................................... 5564 1 36/60 3344
Non-Participants................................ 3816 1 14.5/60 920
---------------------------------------------------------------
Totals...................................... 9380 .............. .............. 4264
----------------------------------------------------------------------------------------------------------------
(Note: reported and calculated numbers differ slightly due to rounding.)
Lynn Susulske,
NHLBI Project Clearance Liaison, National Institutes of Health.
Michael Lauer,
Director, DCVS, National Institutes of Health.
[FR Doc. 2013-23060 Filed 9-20-13; 8:45 am]
BILLING CODE 4140-01-P